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FDA 510(k)

Ultraxx Nephrostomy Balloon Catheter

K-Number: K171601 · 2018-02-23

ApplicantCook Incorporated
Decision Date2018-02-23
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

Ultraxx Nephrostomy Balloon Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-02-23 under approval number K171601. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultraxx Nephrostomy Balloon Catheter?

Ultraxx Nephrostomy Balloon Catheter is a medical device that received FDA 510(k) clearance on 2018-02-23. It is manufactured by Cook Incorporated. The 510(k) number is K171601.

When was Ultraxx Nephrostomy Balloon Catheter approved by the FDA?

Ultraxx Nephrostomy Balloon Catheter received FDA 510(k) clearance on 2018-02-23, under approval number K171601.

What company makes Ultraxx Nephrostomy Balloon Catheter?

Ultraxx Nephrostomy Balloon Catheter is manufactured by Cook Incorporated.

What is the FDA product code for Ultraxx Nephrostomy Balloon Catheter?

The FDA product code for Ultraxx Nephrostomy Balloon Catheter is LJE.

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Related Devices (Code: LJE)

K160077RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture SetJbw7 Innovations, LLC K172527Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque StripeCook Incorporated K181713Ultraxx Nephrostomy Balloon Catheter SetCook Incorporated K172929Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal SheathBoston Scientific Corporation K190903Lawson Retrograde Nephrostomy Wire Puncture SetCook Incorporated K183051Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetCook Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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